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510(k) Data Aggregation

    K Number
    K122974
    Device Name
    TRYOUT-VPS HOLDING PASTE
    Manufacturer
    CROWN DELTA CORP.
    Date Cleared
    2013-05-17

    (233 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Crown Delta's TRYOUT – Translucent Shade VPS Holding Paste is to be used for the temporary stabilization of ceramic crowns and veneers on prepared teeth while the dentist evaluates fit, re-contours and/or trims, and performs an esthetic assessment prior to permanent fixation with cement.

    Device Description

    TRYOUT - Translucent Shade VPS Holding Paste

    AI/ML Overview

    I am sorry, but the provided text from the FDA 510(k) K122974 letter for "TRYOUT - Translucent Shade VPS Holding Paste" does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications that you have requested.

    This document is a letter from the FDA to Crown Delta Corporation stating that their device, TRYOUT - Translucent Shade VPS Holding Paste, is substantially equivalent to a legally marketed predicate device. It confirms the regulatory classification and general controls applicable to the device.

    The "Indications for Use" section (page 3) describes the intended use of the product, but it does not include any performance metrics or study results.

    Therefore, I cannot provide the requested information based on the text provided.

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